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Tovorafenib for Craniopharyngioma in Children and Young Adults
NCT05465174Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2022
- Primary completion
- Mar 2027
- Countries
- 2
- Modality
- Fragment-Derived Small Molecules, Reversible Covalent Inhibitors, Bivalent/Multivalent Binders
- Drugs
- tovorafenib
- Conditions
- craniopharyngioma
01
Overview
Phase 2, open-label trial of tovorafenib in craniopharyngioma (3 arms). Primary endpoints: Progression-Free Survival at 12 months and Pediatric Quality of Life Inventory Physical Functioning Subscale at 12 months. Started Sep 2022; status: recruiting.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Group 1: Neoadjuvant Tovorafenib
Participants with newly diagnosed craniopharyngioma receiving neoadjuvant and maintenance Tovorafenib.
Group 2, Arm A: Neoadjuvant Tovorafenib
Participants with recurrent craniopharyngioma receiving neoadjuvant and maintenance Tovorafenib.
Group 2, Arm B: Non-biopsy/resection participants
Non-biopsy/resection participants with recurrent disease receiving maintenance Tovorafenib.
03
Who it enrols
Children and young adults (1-39 years) with newly diagnosed or recurrent craniopharyngioma, with measurable disease and adequate organ function.
04
Endpoints
Primary
Progression-Free Survival
Pediatric Quality of Life Inventory Physical Functioning Subscale
Secondary
Proportion of participants with visual deficits
Proportion of participants with neuroendocrine deficits
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